The present invention relates generally to adaptors of the type that are used to fluidly interconnect a vial to a needleless syringe and relates more particularly to a novel such adaptor.
Nearly half of all Americans suffer from heartburn at least one month. Heartburn occurs when stomach fluids and acids escape from the stomach and enter into the esophagus, irritating the esophagus. Normally, a muscular ring called the lower esophageal sphincter (LES) acts as a valve between the esophagus and the stomach to allow food to pass from the esophagus into the stomach while keeping stomach fluids and acids from escaping from the stomach into the esophagus. In those instances in which the LES fails to keep stomach fluids and acids in the stomach, heartburn occurs.
For some people who suffer from heartburn, the heartburn is severe enough or frequent enough to disrupt their daily activities and/or their sleep. Such a condition is called gastroesophageal reflux disease (GERD). In some people who have GERD, the LES relaxes more than it should and/or at the wrong times.
In addition to causing frequent and/or severe heartburn, GERD can cause other health problems. For example, the fluids and acids that reflux into the esophagus can lead to inflammation of the esophagus (esophagitis) or ulcers. In severe cases, this damage can scar the esophageal lining and narrow it, causing a stricture which may make it hard or painful for the patient to swallow. In certain cases, this may lead to a condition called Barrett's esophagus, where the lining of the esophagus changes and may over time lead to cancer of the esophagus.
Many people can get relief from GERD symptoms by changing their diet and/or using appropriate medications. Some of the medications available for managing GERD symptoms include common antacids as well as drugs that slow down the production of stomach acids, such as proton pump inhibitors and H2 receptor antagonists.
It should be noted, however, that medications of the type described above merely address symptoms of GERD and do not address the condition's mechanical etiology. Thus, GERD symptoms often recur after drug withdrawal. In addition, while medications may effectively treat the acid-induced symptoms of GERD, they do not treat alkaline reflux, which may result in esophageal mucosal injury.
In any event, because GERD is a chronic condition, it may be necessary for a patient to take medications for the rest of his life in order to continue to obtain relief from GERD symptoms. However, for many patients, the expense and the psychological burden of a lifetime of medication dependence, as well as the uncertainty of long-term effects of some newer medications and the potential for persistent mucosal changes despite symptomatic control, make surgical treatment an alluring alternative to a medicinal approach. As can readily be appreciated, however, surgical intervention, often in the form of anti-reflux surgery, is a major undertaking and includes its own set of risks.
Fortunately, a minimally invasive technique has recently been devised for treating GERD. This technique, which is more fully disclosed in U.S. Pat. Nos. 6,238,335, 6,251,063 and 6,351,064, all of which are incorporated herein by reference, typically involves (i) inserting an endoscope down through the patient's mouth and into the esophagus in proximity to the LES, (ii) then, inserting a catheter having a needle at its distal end down through a channel of the endoscope and into the muscle of the LES, and (iii) then, dispensing a special solution through the catheter and needle and into the muscle of the LES. The solution, which is commercially available from Boston Scientific Corporation (Natick, Mass.) as Enteryx® solution, includes a biocompatible polymer that forms a soft, spongy, permanent implant in the sphincter muscle that helps the LES to keep stomach fluids and acids from backing up into the esophagus.
Typically, the manner in which the Enteryx® solution is loaded into the catheter for injection into the patient is by withdrawing a volume of the solution from a sealed vial using a needle-bearing syringe (i.e., by inserting the tip of the needle through the septum sealing the vial and into the solution contained within the vial and then withdrawing solution from the vial through the needle and into the syringe), detaching the needle from the syringe, and then dispensing the withdrawn volume from the syringe into the catheter. This same technique is also typically used to transfer a liquid primer, typically dimethylsulfoxide (DMSO), from a sealed vial to the catheter.
As can readily be appreciated, the aforementioned use of exposed needles to transfer liquids from sealed vials to the catheter poses certain health and safety risks, such as user injury, exposure to contaminate from the needle and transmission of disease. Accordingly, care must be taken to cap the needle whenever the needle is not in use. Moreover, because the polymeric solution must be injected into the patient at a slow rate, typically requiring the use of a small-volume syringe that must be loaded a plurality of times, the aforementioned use of needles can be quite cumbersome as it is necessary for the needle to be repeatedly attached to and detached from the syringe each time the syringe is loaded with liquid.
Another problem that is posed by the above-described use of needle-bearing syringes to withdraw the polymeric solution and the liquid primer from their respective vials is that there is no way to ensure that the contents of the two vials are being used for the treatment of only one patient. In other words, because the vials typically contain more liquid than is required for one procedure, it is conceivable that the remnants of a plurality of like vials may be combined to treat one or more additional patients. This is undesirable as it may be necessary in certain instances to trace the source of the liquids being administered and/or to prevent the liquids from being used after a certain date.
Although not specifically designed for transferring the particular liquids discussed above, there do exist a number of devices that are adapted for use in transferring liquids from sealed vials to needle-less syringes. One such device is disclosed in U.S. Pat. No. 5,833,213, inventor Ryan, which issued Nov. 10, 1998, and is incorporated herein by reference. The aforementioned Ryan device is a vial adapter that includes a first coupling member having a female luer lock connector with a fluid path therethrough, a flange having a first sealing ring seat formed therein and a first mating structure; a second coupling member having a centrally located septum piercing tube with a fluid path therethrough and a second mating structure; and a valve member including a valve stem and a resilient valve body having an annular sealing surface. A valve body seat is formed in the interior of the second coupling member by a plurality of radially arranged stepped vanes. The second coupling member is formed as a stepped cylinder having a relatively large diameter adjacent the point of the septum piercing tube, a relatively small diameter adjacent the valve body seat and an intermediate diameter therebetween. The valve body is substantially frustoconical having a relatively broad end with a stepped axial bore defining the annular sealing surface. The valve stem has a stepped cylindrical portion which fits into the axial bore of the valve body and a pair of spaced apart upstanding members which extend into the female luer. The vial adapter is attached to a vial by aligning the point of the septum piercing tube with the center of the septum of the vial and by pushing the tube through the septum. As the tube passes through the septum, the neck of the vial is received by the second cylindrical coupling member. When a needleless syringe is attached to the vial adapter, the valve stem is moved towards the vial and the resilient valve body is compressed and moved away from a sealing ring, opening a fluid path from the septum piercing tube into the female luer, and thus into the needleless syringe. When the syringe is removed from the adapter, the resilient valve body expands and seals the fluid path.
Another such device is disclosed in U.S. Pat. No. 5,527,306, inventor Haining, which issued Jun. 18, 1996, and is incorporated herein by reference. The aforementioned Haining patent discloses an adapter for a medicinal vial that includes a conical spike on one end for insertion through the rubber puncture pad in the lid of a medicinal vial. The end opposite the spike is provided with a standard male luer connection and pre-slit rubber cover. The male luer connector of a syringe may be passed through the slit to withdraw liquid from the vial by action of a piston. The rubber cover keeps the end of the adapter sealed. The adapter may include a valve in the upper portion to seal the end which opens in response to the attachment of a syringe.
Examples of other devices for fluidly interconnecting a vial to a needleless syringe are disclosed in the following patents and published patent applications, all of which are incorporated herein by reference: U.S. Pat. No. 6,656,433, inventor Sasso, issued Dec. 2, 2003; U.S. Pat. No. 6,626,309, inventors Jansen et al., issued Sep. 30, 2003; U.S. Pat. No. 6,601,721, inventors Jansen et al., issued Aug. 5, 2003; U.S. Pat. No. 6,599,273, inventor Lopez, issued Jul. 29, 2003; U.S. Pat. No. 6,591,876, inventor Safabash, issued Jul. 15, 2003; U.S. Pat. No. 6,524,295, inventors Daubert et al., issued Feb. 25, 2003; U.S. Pat. No. 6,478,788, inventor Aneas, issued Nov. 12, 2002; U.S. Pat. No. 6,378,714, inventors Jansen et al., issued Apr. 30, 2002; U.S. Pat. No. 6,378,576, inventors Thibault et al., issued Apr. 30, 2002; U.S. Pat. No. 6,378,714, inventors Jansen et al., issued Apr. 30, 2002; U.S. Pat. No. 6,258,078, inventor Thilly, issued Jul. 10, 2001; U.S. Pat. No. 6,189,580, inventors Thibault et al., issued Feb. 20, 2001; U.S. Pat. No. 6,090,093, inventors Thibault et al., issued Jul. 18, 2000; U.S. Pat. No. 6,003,566, inventors Thibault et al., issued Dec. 21, 1999; U.S. Pat. No. 5,620,434, inventor Brony, issued Apr. 15, 1997; U.S. Pat. No. 5,509,433, inventor Paradis, issued Apr. 23, 1996; U.S. Pat. No. 5,429,256, inventor Kestenbaum, issued Jul. 4, 1995; U.S. Pat. No. 5,423,791, inventor Bartlett, issued Jun. 13, 1995; U.S. Pat. No. 4,872,494, inventor Coccia, issued Oct. 10, 1989; U.S. Pat. No. 4,576,211, inventors Valentini et al., issued Mar. 18, 1986; U.S. Pat. No. 2,771,074, issued Nov. 20, 1956; and U.S. Patent Application Publication No. U.S. 2002/0121496 A1, published Sep. 5, 2002.